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ACTIVE NOT RECRUITING
NCT03127995
NA

Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence

Sponsor: UNICANCER

View on ClinicalTrials.gov

Summary

The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas from 5 to 6.5 weeks. Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement have been equally effective and have no more side effects in several clinical trials involving several thousand patients. This called hypofractionated radiotherapy has become a standard for breast cancers in the absence of lymph node involvement in postmenopausal women. The objective of the HypoG01 trial is to evaluate hypofractionated radiotherapy in women who require radiotherapy in the breast or chest wall and lymph node areas by comparing standard over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side effects and in particular the risk of lymphedema (swelling of the arm on the side treated) and the effectiveness of these treatments

Official title: Multicenter Randomized Phase III Trial Comparing Hypofractionated Versus Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation in Terms of Lymphedema Occurrence

Key Details

Gender

FEMALE

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1265

Start Date

2016-09

Completion Date

2030-09

Last Updated

2024-04-09

Healthy Volunteers

No

Interventions

RADIATION

HYPOFRACTIONATED

40 Gy/ 15 fractions / 3 weeks

RADIATION

NORMOFRACTIONATED

50 Gy/ 25 fractions / 5 weeks

Locations (28)

Clinique de l'Europe

Amiens, France

Institut de Cancerologie de L'Ouest-Paul Papin

Angers, France

Hôpital Jean Minjoz

Besançon, France

Institut Bergonie

Bordeaux, France

Centre Jean Perrin

Clermont-Ferrand, France

Hoptal Henri Mondor

Créteil, France

Centre Georges Francois Leclerc

Dijon, France

Centre Guillaume Le Conquerant

Le Havre, France

Centre de radiothérapie Hartmann

Levallois-Perret, France

Centre Galilée - Hôpital Privé La Louvière

Lille, France

Centre Oscar Lambret

Lille, France

Clinique Chenieux

Limoges, France

Hôpital du Scorff

Lorient, France

Centre Leon Berard

Lyon, France

Institut Paoli Calmettes

Marseille, France

ICM Val d'Aurelle

Montpellier, France

Institut de Cancerologie de Lorraine

Nancy, France

Centre Antoine Lacassagne

Nice, France

Hopital Saint-Louis

Paris, France

Institut Curie

Paris, France

Centre Eugene Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

Institut Curie- Rene Huguenin

Saint-Cloud, France

Institut de Cancerologie de L'Ouest-Rene Gauducheau

Saint-Herblain, France

Centre Paul Strauss

Strasbourg, France

Institut Claudius Regaud

Toulouse, France

CHU Bretonneau

Tours, France

Gustave Roussy

Villejuif, France